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Göteborgs universitets publikationer

Challenges to Data Monitoring Committees When Regulatory Authorities Intervene

Författare och institution:
Karl Swedberg (Institutionen för medicin, avdelningen för molekylär och klinisk medicin); J. S. Borer (-); B. Pitt (-); S. Pocock (-); J. Rouleau (-)
Publicerad i:
New England Journal of Medicine, 374 s. 1580-1584
ISSN:
0028-4793
E-ISSN:
1533-4406
Publikationstyp:
Artikel, forskningsöversikt
Publiceringsår:
2016
Språk:
engelska
Fulltextlänk:
Sammanfattning (abstract):
New pharmaceutical agents are best evaluated in randomized, controlled clinical trials in which both the safety of participants and the adequacy of conduct are monitored by an independent data monitoring committee as described in reports from regulatory organizations.1-3 A data monitoring committee can recommend discontinuation of a trial because of futility or because of overwhelming benefit or unacceptable harm associated with an agent, and it can recommend modification of a trial for safety. The data monitoring committee should review relevant contributory information from parallel studies4-8 in order to make appropriate recommendations. Regulatory authorities also must evaluate trial data, . . .
Ämne (baseras på Högskoleverkets indelning av forskningsämnen):
MEDICIN OCH HÄLSOVETENSKAP ->
Klinisk medicin
MEDICIN OCH HÄLSOVETENSKAP ->
Hälsovetenskaper
Postens nummer:
234248
Posten skapad:
2016-04-06 15:46
Posten ändrad:
2016-06-21 14:40

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